Study title
CA180-226 = Dasatinib Powder for Oral Suspension PK Substudy
Scientific title
A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib (ClinicalTrials.gov no NCT00777036)
Indication and most important inclusion criteria
Children up to 18 years old who have chronic phase chronic myeloid leukemia (CP CML) and are taking daily dasatinib (tablets or powder for oral suspension)
Short description of intervention
This is a pharmacokinetic (PK) substudy to evaluate how dasatinib powder formulation in oral solution and dasatinib powder for oral suspension are absorbed, distributed, metabolized in the body and excreted from the body.
Type of study
Pediatric trials
Current status
Active, not recruiting
Study sponsor
Bristol-Myers Squibb
Scientific lead / contact
Mariana Sacchi
mariana.sacchi@bms.com
Principal investigator
Multiple
Additional information
Study centers / principal investigators
Mexico
Mexico City
Instituto Nacional De Pediatria
Romania
Bucharest
Institutul Clinic Fundeni
Spain
Madrid
Hospital Universitario Nino Jesus
USA
Boston
Dana Farber Cancer Institute
Chicago
Children's Hospital of Chicago
Houston
Texas Children'S Cancer Center
Chronic Myeloid Leukemia
also called: Chronic Myelogeneous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
Inclusion criteria
Inlusion criteria define which subjects may participate in a clinical study. Study subjects must fulfill all inclusion criteria (e.g. with regard to sex, age, previous diseases). This ensures a uniform composition of the study population and minimizes the risk of influences that distort the study results.
Chronic phase
The earliest phase of CML development.
Indication
In medicine, a reason to use a certain diagnostic test, therapeutic procedure or medication. The opposite of indication is contraindication.
Dasatinib
Trade name: Sprycel, development name: BMS-354825, inhibits BCR-ABL and SRC tyrosine kinases. Authorized for marketing in the EU since 2006 for the treatment of CML and Ph+ALL.
Other names: BMS-354825|BMS354825|Sprycel
Imatinib
Imatinib, trade name Glivec/Gleevec, development name STI-571, a first-generation BCR-ABL tyrosine kinase inhibition. Authorized for marketing since 2002 for the treatment of CML and Ph-positive ALL.
Other names: Gleevec|Glivec
Chronic
Long-lasting, slowly developping
Oral
Oral, pertaining to the mouth; taken through or applied in the mouth.
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
Ph+
Abbreviation for "Philadelphia-Chromosome-positive", meaning the presence of a certain change in chromosomes (on chromosome 22) found in 95% of patients who have CML. The Philadelphia chromosome results from a mutation that involves the fusion of parts of chromosome 9 and chromosome 22 (the bcr-abl fusion gene).
CHR
Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
